Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain

Completed · Not applicable

Conditions studied: Post Laser Vision Correction Pain and Discomfort

In brief

The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.

Key facts

Study ID

NCT01675375

Run by

FORSIGHT Vision3

People needed

125

Starts

2012-03-01

Expected to finish

2013-02-01

Last updated by the study team

2013-02-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients scheduled to undergo Laser Vision Correction for correction of refractive error
• FDA approved treatment guidelines for Laser Vision Correction
• Age 18-60
• Patients able to understand the requirements of the study, willing to follow study instructions, provide written informed consent to participate, and comply with all study requirements, including the required study follow-up visits

You may not qualify if…

• Any other anterior segment abnormality other than that associated with LAser Vision Correction
• Any abnormalities associated with the eye lids
• Uncontrolled blepharitis or dry eye
• Prior laser treatment of the retina
• Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK
• Diagnosis of glaucoma
• Active diabetic retinopathy
• Clinically significant inflammation or infection within six (6) months prior to study
• Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
• Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material
• Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically
• Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material
• A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
• Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
• Pregnancy

Where it is running

• ClearView Eye and Laser — San Diego, California, United States
• Kraff Eye Institute — Chicago, Illinois, United States
• Talamo Laser Eye Consultants — Boston, Massachusetts, United States
• Physicians Protocol — Greensboro, North Carolina, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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